Temodal iv bula pdf

Robert McWilliams. Lisa Kottschade. A short summary of this paper. Download Download PDF. Translate PDF. Suman, PhD1; Domingo G. Perez, MD2; Robert R.

Kaur, MD1; Thomas T. Geoffroy, MD3; Howard M. Gross, MD4; Peter A. Cohen, MD5; Anthony J. Jaslowski, MD6; Matthew L.

Kosel, BS1; and Svetomir N. Accrual goal was 41 patients per regimen. The primary aim of this study was to estimate progression-free survival rate at 6 months PFS6 in each regimen.

Among the first 41 patients enrolled onto each regimen, PFS6 rate was Cancer ;— V C American Cancer Society. KEYWORDS: metastatic melanoma, chemotherapy, vascular endothelial growth factor inhibition, combination therapy, unresectable metastatic melanoma.

Melanoma affected approximately 60, people in the United States in ,1 with approximately deaths. Both agents were approved in the United States based on completed phase 3 clini- cal trials demonstrating superior survival endpoints of overall survival OS or progression-free survival PFS. In the case Corresponding author: Lisa A. Cloud, MN Donald J. DOI: The primary aim of this study was to independently national therapeutics involving cytotoxic chemotherapy assess the antitumor activity and safety profile of each regi- and inhibitors of angiogenesis in patients with MM.

Vas- men. The study was not designed to compare efficacy cular endothelial growth factor VEGF has been shown between the 2 regimens. The approach of conducting 2 to play a significant role in the natural history of malig- concurrent phase 2 clinical trials with randomization in nant melanoma.

Laboratory evidence demonstrates that ma- sistent evaluation and surveillance. All patients provided signed informed written agent in the context of systemic chemotherapy for MM consent. This study was approved by the institutional may yield antitumor benefits beyond those of chemother- review boards of all participating institutions.

The study data safety monitoring plan included Bevacizumab is a recombinant humanized murine criteria for suspending enrollment to any given regimen monoclonal antibody to VEGF-A that blocks the binding for an unacceptable toxicity. NCI and institutional review boards. Under these con- Thus, in an effort to improve on these observations, we ditions, enrollment to regimen ABC was suspended sought to identify a more effective chemotherapy regimen from June 22, to August 14, , when 9 of the that, in combination with bevacizumab, would yield first 28 patients randomized to regimen ABC developed greater clinical benefit.

As such, we conducted a random- severe thrombosis 3 patients , hypertension 2 ized phase 2 clinical trial in chemotherapy-naive patients patients , dyspnea and fatigue 2 patients , hemorrhage with MM to assess the antitumor activity and safety pro- 1 patient , and oral mucositis 1 patient.

An unexpected jump in accrual rate occurred, lead- of a day cycle repeated until disease progression or ing to 52 total patients being enrolled to this regimen. A stratified of this report. Treatment could be held for up to 4 tion requiring parenteral antibiotics; poorly controlled weeks.

If a patient had a toxicity that was felt to be related months; central nervous system disease primary brain tu- to bevacizumab, patients were to have their dose held or mor, vascular abnormalities ; stroke or transient ischemic discontinued based on the specific toxicity. Under the or have hepatitis. Women who were pregnant or breast assumption that all 41 patients randomized to a given reg- feeding were also not eligible for participation.

If any status, complete blood counts with differential, compre- patients were lost to follow-up within 6 months of regis- hensive metabolic panel including lactate dehydrogen- tration, the 6-month PFS rate would be estimated using ase , urinalysis for proteinuria, and tumor assessment by the Kaplan-Meier method. If a patient died without docu- conventional computed tomography CT , spiral CT, or mentation of progression, the patient was considered to MRI.

Within 28 days of registration, patients underwent have progressed at death. All patients received standard antibodies at 1. The plates were washed and fusions, and growth factor support as clinically blocked for 1 hour at room temperature with reagent dilu- appropriate. TMB substrate and optical density was measured at The plates were washed with phosphate-buffered saline nm wavelength. One patient assigned to regimen ABC withdrew consent prior Median age, y range 57 57 to study treatment.

Therefore, regimen TB included 42 Sex, male Regimen ABC included 51 patients The Immunotherapy Eastern Cooperative Oncology Group performance status 0 The median number of cycles adminis- M1c The most common Grade 3 hypertension — 2. Three patients discontinued treatment due to the Abbreviations: TB, temozolomide and bevacizumab; ABC, nab-paclitaxel, following grade 3 adverse events: pulmonary embolism n carboplatin, and bevacizumab.

Two patients died while on study treatment, including a year-old woman with bone metastases previously treated with radiation who died during cycle 1 from complications of bone marrow suppres- sion and a year-old woman who died during cycle 1 due to rapid disease progression. Regimen ABC Figure 1. The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target called an antigen in the body.

This messenger is involved with inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, CRS and COVID In severe rheumatoid arthritis not previously treated with methotrexate, RoActemra given by infusion was investigated in one main study involving 1, patients. RoActemra, on its own or in combination with methotrexate, was compared with placebo a dummy treatment plus methotrexate.

For the treatment of moderate to severe rheumatoid arthritis where other medicines were unsuccessful, RoActemra given by infusion was studied in five main studies involving a total of over 4, adults. In three of these studies, RoActemra was compared with placebo, as an add-on to failing treatment with conventional rheumatoid arthritis medicines in a total of over 3, patients. Results showed that patients adding RoActemra were around four times more likely to respond to treatment than those adding placebo.

One of the studies, which involved 1, patients, also showed that the combination of RoActemra and methotrexate slowed down the damage to the joints and improved physical function after up to two years, when compared with the combination of placebo and methotrexate. In the fourth study, which included patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around nine times more likely to respond than those receiving placebo with methotrexate.

The fifth study involving patients showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own. Almost 4, patients from these five studies went on to enter studies looking at the long-term effects of RoActemra treatment and results showed that response to RoActemra is maintained for at least two years.

RoActemra given by injection under the skin was investigated in two studies involving 1, patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well. The other study, which compared RoActemra injected under the skin with RoActemra given by infusion, showed that RoActemra injected under the skin was no less effective in achieving a response after six months.

In systemic juvenile idiopathic arthritis, RoActemra given by infusion was compared with placebo in one main study involving children in whom treatment with NSAID and corticosteroids did not work well enough. Another study involving 51 children from 1 year of age showed that RoActemra given by injection under the skin had a similar distribution in the body and effect on the disease to that previously seen with RoActemra given by infusion.

In juvenile idiopathic polyarthritis, RoActemra given by infusion was compared with placebo in one main study involving children from 2 years of age who could not take methotrexate or for whom methotrexate did not work well enough. Patients were allowed to continue treatment with methotrexate during the study. In giant cell arteritis, RoActemra given by injection under the skin was found more effective than placebo in one main study involving adults. All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months.

RoActemra given by infusion was considered to be effective at treating severe CRS based on a review of data from 66 patients who experienced this condition after they were given CAR-T cell medicines to treat a blood cancer. The main measure of effectiveness was based on the number of patients whose CRS resolved within 14 days from the first dose of RoActemra, and who needed no more than two doses of the medicine, and no additional treatment other than corticosteroid medicines.

In severe COVID, one main study showed that treatment with RoActemra given by infusion in addition to standard treatment reduces the risk of death when compared with standard treatment alone. In patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis or cytokine release syndrome, the most common side effects which may affect up to 1 patient in 10 with RoActemra are upper respiratory tract infections nose and throat infection , nasopharyngitis inflammation of the nose and throat , headache, hypertension high blood pressure and abnormal liver function tests.

The most serious side effects are serious infections, complications of diverticulitis a disease affecting the gut and hypersensitivity allergic reactions. In patients with COVID, the most common side effects which may affect up to 1 patient in 10 with RoActemra are high levels of transaminases in the blood a sign of possible liver problems , constipation, and urinary tract infections infections of the structures that carry urine.

Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes.

For the full list of side effects and restrictions, see the package leaflet. Studies show RoActemra is effective at reducing symptoms of several inflammatory conditions. The company that markets RoActemra must supply all doctors expected to prescribe the medicine for rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis and giant cell arteritis with an educational pack containing important information on the safety and correct use of RoActemra.

The pack will also include a patient alert card with key safety information for patients. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of RoActemra have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of RoActemra are continuously monitored.

Side effects reported with RoActemra are carefully evaluated and any necessary action taken to protect patients. RoActemra received a marketing authorisation valid throughout the EU on 16 January More detail is available in the summary of product characteristics. RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis sJIA in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.

RoActemra in combination with methotrexate MTX is indicated for the treatment of juvenile idiopathic polyarthritis pJIA; rheumatoid factor positive or negative and extended oligoarthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.

RoActemra is indicated for the treatment of coronavirus disease COVID in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis sJIA in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.

RoActemra is indicated for the treatment of chimeric antigen receptor CAR T cell-induced severe or life-threatening cytokine release syndrome CRS in adults and paediatric patients 2 years of age and older. Please do not include any personal data , such as your name or contact details. Skip to main content.